1.  Creation, Review and Approval

Create Policy stating regulations and requirements (We do this)

Create Process:  Develop a flowchart for creating, reviewing and approving new documents.

Create Procedure:  The process flowchart tells what procedures are needed.  Source information for procedure steps is found in operators manuals and package inserts.

Review Policy:  Executive management or CEO

Review Process:  Performed at the time of process validation.  All the people involved should verify the flowchart is correct

Review Procedure:  Review for completeness and correctness by the staff who use the procedure.  It is written at the time of process validation

Approval Policy:  Written by Executive management or CEO

Approval Process:  Done by Medical Director, Quality Manager or Respective supervisor

Approval Procedure:   Done by Medical Director, Quality Manager or Respective supervisor

2.  Document ID

No requirements however this is easy to do by type.  Minimum information should be the document title with appropriate wording "......Policy" and a unique ID.  It should list the edition, revision or effective date (version #), the number of pages and the authority for issue.  The facility ID should also be included.

3. Revise:

A formalized process for making changes to approved documents.  All changes are authorized and must not include white out, yellow post it notes, or be obliterated by pen.  Changes need to be reviewed and validated, approved and the revised copies replacing the obsolete copies.

4.  Review

Annual review verifies current, correct and complete documents.   The date, time and by whom is written directly on the document.

5.  Master File

The master file contains all of the approved copies of the current version and copies of previous versions that are now obsolete.  Document change request form would be attached here.  A hard copy is maintained.  This is a historical record for a single document from inception to present.  It lets you look back at what your lab is doing at any given point in time.

6.  Master Index

This is an extended Table of Contents.  It lists all documents in use for the entire lab or section.  It allows staff to ID which version is current and in what location.

example :

  JJJ lab     Version 3     Effective Oct 9 9

Location:  #1  Master file             

                #2  Supervisor's office

                #3  Workstation #1